A Clinical Study to Determine the Safety and Efficacy of an Oral Supplementation of Bio-Immune®for Managing Upper Respiratory Tract Infection and Its Symptoms.

NCT ID: NCT06689995

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-01-29

Brief Summary

This is a prospective, interventional, randomised, double-blind, placebo-controlled, proof-of-science, in-use safety and efficacy study of an oral supplementation of Bio-Immune® for managing upper respiratory tract infection and its symptoms.

Detailed Description

A total of 54 human adults (27/arm) aged 30-80 years with uncomplicated Upper Respiratory Tract Infection will be enrolled to ensure the completion of 50 subjects (25/arm).

Potential subjects will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent. The subject recruitment department will contact the potential subjects via telephone before the enrolment visit to confirm their participation.

Subjects shall be instructed to visit the facility for the following scheduled visits:

• Visit 1 [within 2 days]: Screening, evaluations for inclusion.
• Visit 2 [Day 1]: Enrolment, baseline and post-baseline evaluations, treatment commencement.
• Visit 3 [Day 2]: Test treatment usage phase, follow-up evaluations.
• Visit 4 [Day 3]: Test treatment usage phase, follow-up evaluations.
• Visit 5 [Day 5 (+1 day)]: End-of-study visit, follow-up Evaluations.

Conditions

Upper Respiratory Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Bio-immune Capsule

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg

Group Type: EXPERIMENTAL

Bio-immune Capsule

Intervention Type: OTHER

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg

Placebo Capsule

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days

Interventions

Bio-immune Capsule

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg

Intervention Type: OTHER

Placebo

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1. The age of subject is ≥30 years and <80 years. 2. The subject is a healthy male or a healthy adult non-pregnant and non-lactating female.

3. The subject is suffering from uncomplicated URTI characterized by symptoms such as cough, nasal discharge, sore throat, or has had the first fever spike within 48 hours of enrolment.

4. The subject must be willing to comply with all study procedures and restrictions, including taking the test treatment as directed, completing the WURSS-21 questionnaire, and undergoing laboratory assessments.

5. The subject must provide written informed consent prior to participation in the study.

6. The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.

7. If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.

1. Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).

2. Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.

Exclusion Criteria

• 1. The subject is currently diagnosed with active respiratory infections or diseases other than uncomplicated URTI that might require immediate medical attention or intervention will be excluded.

2. The chest X-ray of the subject, performed within the past 28 days, reveals significant respiratory disorders or other serious conditions that might interfere with the study or necessitate medical intervention.

3. Laboratory tests (blood and urinalysis) performed at the screening visit reveal significant infective or other serious conditions that could interfere with the study or necessitate medical intervention.

4. The subject has known immunocompromising conditions such as HIV/AIDS, or those undergoing immunosuppressive therapy.

5. The subject has other significant respiratory diseases (e.g., COPD, asthma, interstitial lung disease, active tuberculosis).

6. The subject has uncontrolled or severe cardiovascular, renal, or hepatic conditions.

7. The subject has participated in any other clinical trial within 30 days prior to the screening visit.

8. The subject is pregnant/lactating, or is planning on become pregnant during the course of the study.

9. The subject has known hypersensitivity or allergies to any component of the test treatment or similar botanical extracts are excluded.

10. The subject is on regular medications known to interfere with the study outcomes (e.g., systemic corticosteroids, antiviral drugs) within 4 weeks before screening are excluded.

11. The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ambe Phytoextracts Pvt. Ltd

INDUSTRY

Sponsor Role: collaborator

NovoBliss Research Pvt Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Nayan K Patel

Role: PRINCIPAL_INVESTIGATOR

NovoBliss Research Pvt Ltd

Locations

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

NB240047-AP

Identifier Type: -

Identifier Source: org_study_id